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fractions for 5 days a week. Toxicity was recorded using the
CTCAE v4.0 to define a Dose Limiting Toxicity (DLT) and a
Maximum Tolerated Dose (MTD) of MTL005.
Results:
A total of 8 patients, 7 males (88%) and 1 female
(12%), were enrolled, 4 in each of the 2 dose level cohorts.
Six patients, all male with median age of 65 (54-77), were
dosed with MTL005 successfully, 3 in each cohort. Dosing
failures were due to an unexpected severe pain reaction (1
patient) and a technical problem with the infusion line (1
patient). In the 6 evaluable patients the following adverse
events were recorded. Grade ≤2 oral mucositis and dysphagia
were recorded in 3 (50%) and 4 (67%) patients respectively.
Grade 1 pain in site of MTL005 injection was assessed in 1
(17%) patient. Grade ≤2 other toxicities (anaemia, dysgeusia)
occurred in 3 (50%) patients. Grade 3 (dyspnoea,
pneumonitis, oral haemorrhage, back pain, hyperuricemia)
and Grade 4 toxicity (sepsis) were recorded in 4 (67%) and 1
(17%) cases respectively requiring hospitalisation and being
considered as Serious Adverse Events (SAE). None of the SAE
was assessed as directly related to MTL005 so DLT/MTD was
not defined.
Conclusion:
We completed Part 1 of the study and MTL005
DLT/MTD was not defined. Part 2 has been commenced with
a MTL005 starting dose of 4mg/kg and is currently ongoing.
EP-1049
Prognostic role of 18F-FDG PET/CT in head and neck
cancers treated with radical radio-chemotherapy
I. Sandler
1
Nuclear Medicine Unit- S.Orsola-Malpighi Hospital-
University of Bologna, Department of Experimental-
Diagnostic and Specialty Medicine-DIMES, Bologna, Italy
1
, P. Castellucci
1
, S. Fanti
1
, U. Caliceti
2
, R. Frakulli
3
,
A. Milani
3
, S. Cammelli
3
, F. Deodato
4
, M. Nuzzo
4
, G. Macchia
4
,
G. Frezza
5
, A.G. Morganti
3
2
Unit of Otolaryngology- S.Orsola-Malpighi University
Hospital, Department of Specialist Surgery and
Anesthesiology, Bologna, Italy
3
Radiation Oncology Center- S.Orsola-Malpighi Hospital-
University of Bologna, Department of Experimental-
Diagnostic and Specialty Medicine-DIMES, Bologna, Italy
4
Fondazione di Ricerca e Cura "Giovanni Paolo II"- Catholic
University of Sacred Heart, Radiotherapy Unit, Campobasso,
Italy
5
Ospedale Bellaria, Radiotherapy Department, Bologna, Italy
Purpose or Objective:
To assess the prognostic role of 18F -
FDG PET/CT based response evaluation after primary
concomitant radio-chemotherapy (RCT) for loco regionally
advanced Head and Neck squamous cell carcinoma (HNSCC).
Material and Methods:
150 patients were included in this
retrospective study. Mean age was 59 years (107 males and
43 females). The sites of HNSCC were oropharynx (53%),
nasopharynx (14%), oral cavity (10%), hypopharynx (7%),
larynx (7%), salivary glands (5%) and paranasal sinuses (4%).
All patients underwent 18F-FDG PET/CT between 2006 and
2013 to assess treatment response; 62% of patients also had a
pre-therapy 18F -FDG PET/CT scan. 18F -FDG PET/CT was
performed from 6 to 36 weeks (median 21 weeks) after the
end of RCT. Patients were divided in three groups: 18F -FDG
PET/CT performed from 6 to 14 weeks after the end of RCT
(group I: 30 patients), from 15 to 23 weeks (group II: 89
patients) and from 24 to 36 weeks (group III: 31 patients).
18F -FDG PET/CT scans were performed according to
standard procedure, then they were visually analysed by 2
expert physicians and categorized as negative (“score 1”),
doubt negative (“score 2”), doubt positive (“score 3”) and
positive (“score 4”). Patients were followed-up, based on
clinic and radiological and/or histological findings. Median
follow up was 38 months (range, 12-60 months). At the end
of the follow-up 18F-FDG PET/CT were classified as true
positive (TP), true negative (TN), false positive (FP) and false
negative (FN).
Results:
Group I showed “score 1” in 14 patients, “score 4”
in 11 patients and therefore 18F-FDG PET/CT sensitivity was
69%, specificity 83%, VPP 82%, VPN 72%, and accuracy 0.76.
This group showed 5 doubt scans (16%) as “score 2” that were
find out to be 2 negatives and 3 positives. No “score 3” was
observed in this group. Group II showed “score 1” in 55
patients, “score 4” in 27 patients and therefore 18F-FDG
PET/CT sensitivity was 87%, specificity 98%, VPP 96%, VPN
93%, and accuracy 0.94. This group showed 7 (8%) doubt
scans: 3 scans (3.5%) as “score 2” that in follow-up were 1
negative and 2 positives and 4 scans (4.5%) as “score 3” that
were found out to be 2 negatives and 2 positives. Group III
showed “score 1” in 24 patients and “score 4” in 6 patients
and therefore 18F-FDG PET/CT sensitivity was 86%,
specificity 100%, VPP 100%, VPN 96%, and accuracy 0.97. This
group showed only 1 doubt scan (3%) as “score 2” that was
find out to be negative.
Conclusion:
According to our data, PET/CT with 18F-FDG
showed an excellent prognostic value of treatment response
to primary concomitant RCT if performed at least 14 weeks
after the end of RCT. We also observed that the numbers of
“doubt scans” significantly decrease 14 weeks after the end
of RCT.
EP-1050
Volume definition in radiotherapy planning for thyroid
cancer: a retrospective observational study
E. Farina
1
Radiation Oncology Center- Sant'Orsola-Malpighi Hospital-
University of Bologna, Department of Experimental-
Diagnostic and Specialty Medicine- DIMES, Bologna, Italy
1
, S. Cammelli
1
, A. Arcelli
1
, G. Zanirato
1
, R. Frakulli
1
,
L. Tagliaferri
2
, A.G. Morganti
1
, S. Fanti
3
, F. Monari
1
2
Policlinico Universitario “A. Gemelli”- Università Cattolica
del Sacro Cuore, Department of Radiotherapy, Roma, Italy
3
Nuclear Medicine Unit- Sant'Orsola-Malpighi Hospital-
University of Bologna, Department of Experimental-
Diagnostic and Specialty Medicine- DIMES, Bologna, Italy
Purpose or Objective:
The role of post-operative external
beam radiotherapy (EBRT) in differentiated thyroid
carcinomas is still discussed considering the low clinical
aggressiveness and the possibility to perform a radioiodine
ablation (RAI). However, there are dedifferentiated tumors
that, over time, lose their capacity to capture Iodine. The
aim of this study is to evaluate the utility of 18F-FDG PET/CT
in volumes defining and the clinical response rate after EBRT
in these patients.
Material and Methods:
Patients with locally recurrent thyroid
cancer, treated with radical EBRT from October 2011 to
March 2015 after total thyroidectomy and RAI, were included
in the study. When EBRT was planned, thyroglobulin (HTG)
was detectable and there was negative post-RAI whole body
scintigraphy (WBS) and no surgical indications. All patients
underwent a pre-treatment 18F-FDG PET/CT that resulted
positive: 3 in loggia, 3 in loggia and lymph nodes, 9 in lymph
nodes, 1 in lymph nodes and in lung. EBRT was delivered with
IMRT-SIB technique: a dose of 66 Gy (2.2 Gy/fr) to increased
FDG-uptake areas, 60 Gy (2 Gy/fr) to ipsilateral lymph nodes
and 54 Gy (1.8 Gy/fr) to contralateral ones, in 30 fractions, 1
fr/die. A revaluation 18F-FDG PET/CT and HTG dosage during
the follow-up (range: 5-43 months) was performed. Acute
and late toxicity were assessed with CTCAE v. 4.03 and
EORTC-RTOG scales respectively, the metabolic, clinical and
instrumental response with PERCIST and RECIST criteria.
Local control (LC) and overall survival (OS) were analysed
with Kaplan-Meier method.
Results:
Sixteen patients were treated and analyzed
consecutively [M / F: 8/8; median age: 71 years; range: 36-
81; histology: 15 papillary carcinomas and 1 follicular
carcinoma; UICC stage: III-IV]. Post-EBRT 18F-FDG PET/CT
showed CR in 7 (43.8%), PR in 5 (31.2%), SD in 4 (25.0%)
patients and unknown lung metastases in 2 patients (12.5%).
HTG decreased in agreement with PET/CT results. 4 patients
(25.0%) had G3 skin acute toxicity and no one showed G4 late
toxicity. LC and OS rates were 100% at last follow-up (median
F-UP: 12.3 months).